Multi-component expandable supportive bifurcated endoluminal grafts and methods for using same

ABSTRACT

A multiple-component expandable endoluminal system for treating a lesion at a bifurcation including a self expandable tubular root member having a side-looking engagement aperture, a self expandable tubular trunk member comprising a substantially blood impervious polymeric liner secured therealong; both having a radially compressed state adapted for percutaneous intraluminal delivery and a radially expanded state adapted for endoluminal support.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is the US National Stage of International PatentApplication PCT/IL2008/000287, filed Mar. 5, 2008, which claims thebenefit of U.S. Provisional Applications 60/892,885, filed Mar. 5, 2007,and 60/991,726, filed Dec. 2, 2007.

FIELD OF THE INVENTION

The present invention relates generally to endoluminal grafts, andparticularly to bifurcated endoluminal grafts.

BACKGROUND OF THE INVENTION

For a few decades, conventional treatment of abdominal aortic aneurysms(AAA) was limited either to a sit-and-wait strategy, or in cases withtoo high a risk for aneurysm rupture, a surgical operation usingvascular grafts introduced in major open abdominal surgery.

While long term clinical results of the surgical approach were favorableand the treated patients did not need frequent follow-ups, neverthelessthe short-term morbidity, including complication rate, hospitalizationtime, out-of-work period and related expenses warranted continued searchfor a less invasive, but still definitive, solution of the problem.

Numerous attempts have been made to introduce such definitive treatmentsto AAA that involve less morbidity, a shorter hospitalization period andlower related costs, and enable the patient to return to routine lifesooner. These initiatives resulted in various endovascular stent-graftsthat are commercially available or are being clinically andpre-clinically evaluated. A major advantage in these newer devices isthat their implantation involves a significantly less invasiveprocedure, including creating an endovascular working channel—usuallyvia an incision in the groin area—to the diseased abdominal aorta,through which a self expandable stent-graft is typically introduced. Inmost cases, a bifurcated device is employed, either in one piece, or insome cases, smaller caliber iliac-grafts are deployed subsequently afterthe main aortic devices have been well positioned.

Nonetheless, the relatively new endovascular approach has its share ofproblems and limitations. Some of the major outstanding problemsinclude:

-   -   The implantation is complicated because most AAA stent grafts        are implanted via two working channels, one in each side of the        groin. The interventional radiologist typically has to introduce        one main piece of the device via one working channel and an        extension piece through the other side in a non trivial manner.    -   There is a prolonged implantation procedure caused by a        difficulty to correctly position the stent-graft and the        inability to correct its position once deployed, usually due to        barbs that penetrate the aortic wall and anchor the graft        thereto. This also involves relatively high doses of X-ray        radiation, to which the patient and the staff are exposed during        the prolonged endovascular procedure.    -   In earlier AAA stent grafts, device migration was a major issue,        sometimes leading to obstruction of blood flow into the        neighboring renal arteries or in other cases exposing the        aneurysm to renewed blood penetration. Conventional AAA        stent-grafts were typically prone to migration since they are        essentially built along a single longitudinal axis and they may        migrate along the same axis.    -   Endovascular leaks (in short—endoleaks) are another problem. Two        types of endoleaks are defined: A type I endoleak is leakage of        blood around the stent-graft and into the aneurismal sac, which        may lead to rupturing the aneurysm. A Type II endoleak occurs        when blood/plasma leaks through the graft wall and into the        aneurismal space. Type II endoleaks have been mostly resolved by        the introduction of finer-woven graft fabrics, performing        pre-clotting procedures and/or incorporation of collagen or        other procoagulation materials into the graft wall. Type I        endoleaks are nonetheless more difficult to prevent and treat.    -   The device cost is very high. Current self-expandable AAA        stent-grafts are usually bifurcated grafts, one piece or        multi-piece devices. The connection with the graft fabric is        typically achieved by hand stitching to a metallic,        self-expandable frame. Hand labor related issues together with        the critical QA/QC standards with which these devices have to        comply make these devices quite expensive to manufacture.    -   There are the necessary follow-ups which are time consuming.

SUMMARY OF THE INVENTION

The present invention seeks to provide novel bifurcated endoluminalgrafts that overcome the abovementioned problems of the prior art, asdescribed more in detail hereinbelow. The present invention seeks toreduce the laborious and complicated multi-step medical procedures andrelated cost of the device. The present invention involves significantlyfewer, simpler, quicker and more definitive medical steps. The presentinvention uses simpler device modules, which make the endovasculartreatment of AAA quicker, safer for the patient and the treating staff,more reliable and cheaper.

The present invention can reduce the number of vascular access sitesfrom two femoral arteries in both sides of the groin to a singlevascular access site. The present invention can reduce the risk ofdevice migration in AAA stent grafts.

There is provided in accordance with an embodiment of the invention astent graft system including a first component 60 including a tubularstructure having a support element 63 and a covering element 62 attachedthereto, the first component 60 being positionable in first and secondbranches that bridge a main trunk of a subject and wherein the first andsecond elements have an opening 61 arranged to face the main trunk, anda second component 70 having a generally cylindrical form with a supportelement 72 and a covering element 71 attached thereto, the secondcomponent 70 configured to be at least partially disposed within thefirst component 60 outwardly extending from the opening 61 in the firstcomponent 60.

One or both of the first and second components may be adapted fortransluminal delivery for transport to a site within a body lumen bybeing radially compressed from a larger cross-section to a smallercross-section.

In accordance with an embodiment of the invention the covering elementof the first component only partially covers the support element of thefirst component.

In accordance with an embodiment of the invention the covering elementof the second component only partially covers the support element of thesecond component.

Further in accordance with an embodiment of the invention the first andsecond components are radially compressible from a larger cross-sectionto a smaller cross-section, and wherein the first and second componentsare adapted for transluminal delivery for transport to a site within abody lumen, and wherein the second component is adapted for transluminaldelivery through the first component in its larger cross-section and tooutwardly extend from the opening in the first component. For example,the first component in its larger cross-section may be dimensioned tointraluminally fit iliac arteries of a subject and the second componentin its larger cross-section may be dimensioned to intraluminally fit anabdominal aorta of the subject.

In accordance with an embodiment of the invention the second componentincludes a proximal segment and a distal segment, and wherein thecovering element substantially spans the distal segment but does notgenerally span the proximal segment. The proximal segment may bedimensioned to be anchorably disposed within the first component. Theproximal segment of the second component may be substantially disposedwithin the first component. The distal segment of the second componentmay outwardly extend from the opening in the first component.

There is provided in accordance with an embodiment of the invention amethod including implanting a stent graft system into a bifurcation in abody lumen, the bifurcation including a main trunk and first and secondbranches, wherein a first component of the system is disposed within thefirst and second branches bridging the main trunk and wherein the firstand second elements have an opening aligned to face the main trunk, andimplanting a second component in the main trunk such that at least aportion of the second component is located within the main trunk and atleast a portion of the second component is located within the firstcomponent.

There is provided in accordance with an embodiment of the invention amultiple-component expandable endoluminal system for treating a lesionat a bifurcation including a self expandable tubular root member havinga side-looking engagement aperture, a self expandable tubular trunkmember including a substantially blood impervious polymeric linersecured therealong, both having a radially compressed state adapted forpercutaneous intraluminal delivery and a radially expanded state adaptedfor endoluminal support, wherein root member and the trunk member areindividually deployable, and wherein the trunk member is substantiallynon compressible along its longitudinal axis, and wherein thecircumference of the side-looking engagement aperture is capable ofhaving a substantially identical shape as the circumference of the bodyportion of the trunk member in its radially relaxed state, and whereinthe trunk member is adapted to be inserted intraluminally through eitherends of root member when in its deployable state and thereafterextraluminally substantially exiting through its side-looking engagementaperture and perpendicular thereto, and wherein the distal end of trunkmember is adapted to be anchorably deployable through the side-lookingengagement aperture.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more fully fromthe following detailed description, taken in conjunction with thedrawings in which:

FIG. 1 is a simplified pictorial illustration of one possible insertionstep in the deployment of an endoluminal graft in a non-limitingembodiment of the present invention;

FIG. 2 is a simplified pictorial illustration of another deployment stepof the endoluminal graft in a non-limiting embodiment of the presentinvention;

FIG. 3 is a simplified pictorial illustration of a stent graft componentof the endoluminal graft free of its catheter and positioned such thatit has an open end located within each bifurcation branch and anaperture is facing the main trunk;

FIG. 4 is a simplified pictorial illustration of another deployment stepof the endoluminal graft in a non-limiting embodiment of the presentinvention;

FIG. 5 is a simplified pictorial illustration of another deployment stepof the endoluminal graft in a non-limiting embodiment of the presentinvention;

FIG. 6 is a simplified pictorial illustration of the stent graft systemin place in accordance with an embodiment of the present invention;

FIGS. 7-12 are simplified pictorial illustrations of another preferredembodiment of the present invention, wherein a catheter is inserted in afashion similar to the embodiments of FIGS. 4-6;

FIG. 13 is a simplified pictorial illustration of a non-limitingembodiment of an anchoring mechanism between first and second stentgraft components;

FIG. 14 is a simplified pictorial illustration of another non-limitingembodiment of an anchoring mechanism between stent graft components;

FIG. 15A is a simplified pictorial illustration of a non-limitingembodiment of a stent graft component with an aperture evident in thegraft material;

FIGS. 15B and 15C are simplified pictorial illustrations of anon-limiting embodiment of stent graft component wherein the componentincludes sections with varying diameters; and

FIGS. 16A and 16B are simplified pictorial illustrations of the flow ofblood through the joined stent graft components.

DESCRIPTION OF EMBODIMENTS

Reference is now made to FIG. 1, which illustrates one possibleinsertion step in the deployment of a component of an endoluminal graftin a non-limiting embodiment of the present invention. A catheter 100 ispercutaneously inserted into a bifurcation 12 (e.g., one iliac artery)extending from a main trunk 10, using conventional transluminal methods,such as with a guidewire 50. The catheter 100 is bent or deflected at anangle so that it passes the main lumen and is then introduced into asecond bifurcation 13 (e.g., the second iliac artery) extending from themain trunk 10. FIG. 1 shows two branch arteries (arterial ostia) 14 and15 branching from main trunk 10. There is an aneurysm 11 in the maintrunk 10. Catheter 100 includes two catheter portions 101 and 102.Bifurcations 12 and 13 may also be referred to as arterial ostia 12 and13.

Reference is now made to FIG. 2, which illustrates another deploymentstep of a component in a non-limiting embodiment of the presentinvention. Both the distal and proximal ends of the catheter portions101 and 102, respectively, are moved in opposite directions (e.g., bysuitable manipulation of guide wires attached thereto, not shown) sothat a stent graft component 60 which is in a compressed state withinthe catheter is gradually freed. An aperture 61 in the stent graftcomponent 60 is positioned by the operator (e.g., by suitablemanipulation of a guide wire attached thereto, not shown, and assistedby imaging such as fluoroscopy) such that it faces the main trunk 10.FIG. 3 illustrates the stent graft component 60 free of its catheter andpositioned such that it has an open end located within each bifurcation12 and 13 respectively, while aperture 61 is facing the main trunk 10.

Reference is now made to FIG. 4, which illustrates another deploymentstep of a component in a non-limiting embodiment of the presentinvention. A second catheter 200 is inserted through one open end of thefirst stent graft component 60 so that its distal end extend through theaperture 61 in the first stent graft component and is located within themain trunk 10.

Reference is now made to FIG. 5, which illustrates another deploymentstep of a component in a non-limiting embodiment of the presentinvention. A second stent graft component 70 is gradually freed from itsrestraining catheter. Catheter outer tube 202 is withdrawn so that thestent graft component 70 is gradually free to expand in a radialdirection, such that the graft component's distal end engages the wallsof the main trunk 10 below arterial ostia 12 and 13, for example, therenal artery ostia. As the second stent graft component 70 is freed fromthe circumferential confines of the outer catheter tube 202, itsproximal end engages the first stent graft component 60, thus anchoringthe second stent graft component 70 to the first stent graft component60.

FIG. 6 schematically illustrates the stent graft system in place, withthe second stent graft component 70 having one end engaged radiallyagainst the wall of the main trunk 10 under arterial ostia 12 and 13,while its proximal end is concentrically located within one end of thefirst stent graft component 60.

FIGS. 7 through 12 illustrate another preferred embodiment of thepresent invention, wherein a catheter 70 is inserted in a fashionsimilar to the one described in FIGS. 4, 5 and 6. Stent graft component70 is freed from its catheter 200 by retracting outer catheter tube 202so that its distal end is free within the main trunk lumen. The distalend of said second stent graft component 70 may or may not touch thelumen walls of the main trunk. The proximal end of the second stent islocated concentrically within one section of the first stent graftcomponent 60 so that it is anchored by the first stent graft component.A catheter 300 is inserted in a similar fashion through an open end ofthe first stent graft component 60, and through the proximal end of thesecond stent graft component 70 located concentrically within the firststent graft component 60. Catheter 300 is inserted such that itsproximal end extends beyond the open distal end of the second stentgraft component 70. A third stent graft component 80 is released fromthe catheter so that its distal end radially engages the lumen walls ofthe main trunk 10. As the third stent graft component 80 is furtherreleased, its proximal end engages the second stent graft component 70in a radial fashion, forming an anchoring point between the second stentgraft component 70 and the third stent graft component 80.

FIG. 12 shows elements of stent graft component 80 engaging the lumenwalls of main trunk 10 such that support elements 82 engage the lumenwall above arterial ostia 12 and 13. Graft covering 81 does not extendabove the arterial ostia so as not to block blood flow into the ostia 14and 15.

FIG. 13 schematically illustrates a non-limiting embodiment of theanchoring mechanism between the first stent graft component 60 and thesecond stent graft component 70. In this embodiment, engagement arms 73and 74 are located circumferentially on the second stent graft component70 in at least two rows above and below aperture 61 in stent graftcomponent 60. The rows of engagement arms 73 and 74 are formed so as tograsp both sides of aperture 61 in stent graft component 60. The twostent graft components are joined together as a result.

FIG. 14 schematically illustrates another non-limiting embodiment of theanchoring mechanism between stent graft component 60 and stent graftcomponent 70 whereby the proximal end of stent graft component 70 isconcentrically located within at least a portion of stent graftcomponent 60 with a section of the second stent graft component 70extending through the aperture 61 and within a portion of stent graftcomponent 60. The graft covering 71 does not necessarily extendthroughout the length of stent graft component 70.

FIG. 15A schematically illustrates a non-limiting embodiment of stentgraft component 60 wherein aperture 61 is evident in the graft materialcovering component 61. The graft covering 62 may be connected to supportsection 63 by means of sutures, adhesives or any suitable means.Aperture 61 in the graft covering 62 may be equal in size to theaperture affected in support structure 63. Flaring may be introduced tocomponent ends 65 in order to better engage a body lumen (not shown)when implanted.

FIGS. 15B and 15C schematically illustrates a non-limiting embodiment ofstent graft component 70 wherein component 70 may have include sectionswith varying diameters, so that a portion of component 70 may bedeposited within a section of component 60 (not shown). FIG. 15C showsanother embodiment wherein circumferential engagement arms 74 may beformed so as to engage portions of component 60 (not shown) so as toanchor both components together.

FIGS. 16A and 16B show the flow of blood through the joined stent graftcomponents 60 and 70. It is important to allow blood flow to both sidesof component 60 so as not to cause ischemia. FIG. 16B illustrates thatcomponent 70 is not covered throughout by a graft covering so as toallow blood flow to both sides.

The scope of the present invention includes both combinations andsubcombinations of the features described hereinabove as well asmodifications and variations thereof which would occur to a person ofskill in the art upon reading the foregoing description and which arenot in the prior art.

1. A stent graft system comprising: a first component, which comprises atubular structure, which comprises a first support element and a firstcovering element attached to said first support element, two sides ofsaid first component being positionable, respectively, in first andsecond branches that branch from a main trunk of a subject, wherein saidfirst covering element is shaped so as to define an opening arranged toface said main trunk; and a second component, which comprises a secondsupport element and a second covering element attached to said secondsupport element, said second component partially disposed within saidfirst component, extending out of said first component through saidopening, wherein said second component comprises a proximal segment anda distal segment, said proximal segment being anchorably disposed withinexactly one of said two sides of said first component, such that saidproximal segment engages said exactly one side, and wherein said distalsegment of said second component extends out of said first componentthrough said opening, and wherein said second covering element onlypartially covers said second support element so as to allow blood flowto both of said two sides of said first component.
 2. The stent graftsystem according to claim 1, wherein said first component is adapted fortransluminal delivery for transport to a site within a body lumen bybeing radially compressed from a larger cross-section to a smallercross-section.
 3. The stent graft system according to claim 1, whereinsaid second component is adapted for transluminal delivery for transportto a site within a body lumen by being radially compressed from a largercross-section to a smaller cross-section.
 4. The stent graft systemaccording to claim 1, wherein said first covering element only partiallycovers said first support element.
 5. The stent graft system accordingto claim 1, wherein said first and second components are radiallycompressible from respective larger cross-sections to respective smallercross-sections, wherein said first and second components are adapted fortransluminal delivery for transport to a site within a body lumen, andwherein said second component is adapted for transluminal deliverythrough said first component when said first component assumes itslarger cross-section.
 6. The stent graft system according to claim 5,wherein said first component, when it assumes its larger cross-section,is dimensioned to intraluminally fit iliac arteries of said subject, andwherein said second component, when it assumes its larger cross-section,is dimensioned to intraluminally fit an abdominal aorta of said subject.7. The stent graft system according to claim 1, wherein said secondcovering element substantially covers said distal segment but does notgenerally cover said proximal segment.
 8. The stent graft systemaccording to claim 1, wherein said second covering element substantiallycovers said distal segment, covers a proximal portion of said proximalsegment, and does not cover a distal portion of said proximal segment.9. The stent graft system according to claim 1, wherein said secondcomponent includes sections having varying diameters, such that aportion of said second component is disposable within a section of saidfirst component.
 10. The stent graft system according to claim 1,wherein a diameter of a distal section of said distal segment notdisposed within said first component is greater than a diameter of saidopening, and wherein said diameter of said distal section increases assaid distal section exits from said opening.
 11. The stent graft systemaccording to claim 1, wherein a section of said second covering elementextends through said opening and within a portion of said firstcomponent when said proximal segment is anchorably disposed within saidexactly one of said two sides of said first component.
 12. The stentgraft system according to claim 1, wherein said proximal segment of saidsecond component is concentrically located within at least a portion ofsaid first component when said proximal segment is anchorably disposedwithin said exactly one of said two sides of said first component. 13.The stent graft system according to claim 1, wherein said firstcomponent widens in a vicinity of said opening.
 14. The stent graftsystem according to claim 1, wherein said first component is configuredsuch that a perimeter of said opening is less than a perimeter ofsupports of said first component surrounding said opening, such that aportion of said first covering element surrounding said opening extendsfrom said supports towards said opening.
 15. The stent graft systemaccording to claim 1, wherein said second component has a generallycylindrical form.
 16. A method comprising: implanting, respectively infirst and second iliac arteries that branch from an abdominal aorta of asubject, two sides of a first component of a stent graft system, whichfirst component includes a first support element and a first coveringelement attached to said first support element, such that an openingdefined by said first covering is aligned to face said abdominal aorta;and thereafter, implanting a second component of said system, whichsecond component includes a second support element and a second coveringattached to said second support element, by: transluminally advancing acatheter tube through one open end of exactly one of said two sides ofsaid first component and out through the opening into the abdominalaorta, while said second component is radially compressed within saidcatheter tube, and withdrawing said catheter tube so that (a) at least adistal segment of said second component is freed from said catheter tubeand radially expands within said abdominal aorta, and (b) thereafter, atleast a proximal segment of said second component is freed from saidcatheter tube and radially expands within said exactly one of said twosides of said first component, thereby anchoring said at least aproximal segment of said second component to said first component,wherein said second covering element only partially covers said secondsupport element so as to allow blood flow to both of said two sides ofsaid first component.
 17. The method according to claim 16, wherein saidsecond covering element substantially covers said distal segment butdoes not generally cover said proximal segment.
 18. The method accordingto claim 16, wherein said second covering element substantially coverssaid distal segment, covers a proximal portion of said proximal segment,and does not cover a distal portion of said proximal segment.
 19. Themethod according to claim 16, wherein said second component includessections having varying diameters, such that a portion of said secondcomponent is disposable within a section of said first component. 20.The method according to claim 16, wherein anchoring said at least aproximal portion of said second component comprises disposing saidsecond component such that a section of said second covering elementextends through said opening and within a portion of said firstcomponent.
 21. The method according to claim 16, wherein anchoring saidat least a proximal segment of said second component comprisesconcentrically locating said at least a proximal segment of said secondcomponent within at least a portion of said exactly one of said twosides of said first component.
 22. The method according to claim 16,wherein said catheter tube is a second catheter tube, and whereinimplanting said first component comprises transluminally delivering saidfirst component by: advancing a first catheter tube into said first andsecond iliac arteries, while said first component is radially compressedwithin said first catheter tube, and thereafter freeing said firstcomponent from said first catheter tube such that said first componentradially expands in said first and second iliac arteries.
 23. The methodaccording to claim 16, wherein said second component is generallycylindrical.
 24. The method according to claim 16, wherein withdrawingsaid catheter tube comprises withdrawing said catheter tube such thatsaid distal segment that radially expands within said abdominal aortahas a diameter that (a) is greater than a diameter of said opening, and(b) increases as said distal segment exits from said opening.